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Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00358917
First received: July 28, 2006
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
  Purpose

The purpose of this study was to compare the safety, tolerability, and antiviral activity of once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects with detectable viral load while receiving their current antiretroviral therapy.


Condition Intervention Phase
Human Immunodeficiency Virus Infections
 Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label Study of Lopinavir/Ritonavir (LPV/r) Tablets 800/200 Milligram (mg) Once-Daily (QD) Versus 400/100 mg Twice-Daily (BID) When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in Antiretroviral-Experienced, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm [ Time Frame: Week 48 (End of Study) ] [ Designated as safety issue: No ]
    A participant was classified as a responder at the first of 2 consecutive human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL. The participant continued to be a responder until 2 consecutive values >=50 copies/mL were reached, until the final value if that value was >=50 copies/mL, or until discontinuation or death.


Secondary Outcome Measures:
  • Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48 [ Time Frame: Week 48 (End of Study) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts [ Time Frame: Week 48 (End of Study) ] [ Designated as safety issue: No ]
  • Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir [ Time Frame: Week 48 (End of Study) ] [ Designated as safety issue: No ]
    Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.

  • Percentage of Participants With New Primary Protease Mutations at Week 48 [ Time Frame: Week 48 (End of Study) ] [ Designated as safety issue: No ]
    Emergence of new primary protease inhibitor mutations (i.e., mutations at codons 30, 32, 48, 50, 82, 84, and 90 that were not present at baseline).


Enrollment: 599
Study Start Date: August 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LPV/r 800/200 mg QD Tablet Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
LPV/r 800/200 mg once-daily (QD) tablet
Other Names:
  • ABT-378
  • lopinavir/ritonavir
  • Kaletra
Active Comparator: LPV/r 400/100 mg BID Tablet Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
LPV/r 400/100 mg twice-daily (BID) tablet
Other Names:
  • ABT-378
  • lopinavir/ritonavir
  • Kaletra

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral-experienced adults at least 18 years of age currently receiving an antiretroviral regimen which had not changed for at least 12 weeks.
  • Subjects had plasma HIV-1 ribonucleic acid (RNA) levels > 1,000 copies/mL at screening and were not acutely ill.
  • Subject was currently failing his/her antiretroviral regimen with the most recent 2 consecutive prestudy plasma HIV-1 RNA levels > 400 copies/mL with the most recent being > 1000 copies/mL, and in the investigator's opinion, should change therapy
  • Female subjects were nonpregnant and nonlactating.

Exclusion Criteria:

  • Subjects were excluded if screening laboratory analyses showed hemoglobin <= 8.0 grams per deciliter.
  • Subjects were excluded if screening laboratory analyses showed absolute neutrophil count <= 750 cells/microliter.
  • Subjects were excluded if screening laboratory analyses showed platelet count <= 50,000 per cubic millimeter.
  • Subjects were excluded if screening laboratory analyses showed alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 5.0 x upper limit of normal (ULN).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358917

Locations
United States, Illinois
Medical Information - Abbott (1-800-633-9110)
Abbott Park, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Investigators
Study Director: Thomas J Podsadecki, MD Abbott
  More Information

No publications provided

Responsible Party: Barry Bernstein, MD, Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00358917     History of Changes
Other Study ID Numbers: M06-802
Study First Received: July 28, 2006
Results First Received: November 12, 2009
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Reverse Transcriptase Inhibitors
Ritonavir
 Lopinavir
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 16, 2013